ISSN 1977-0677 |
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Official Journal of the European Union |
L 132 |
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English edition |
Legislation |
Volume 62 |
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(1) Text with EEA relevance. |
EN |
Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period. The titles of all other Acts are printed in bold type and preceded by an asterisk. |
II Non-legislative acts
REGULATIONS
20.5.2019 |
EN |
Official Journal of the European Union |
L 132/1 |
COUNCIL IMPLEMENTING REGULATION (EU) 2019/798
of 17 May 2019
implementing Regulation (EU) No 36/2012 concerning restrictive measures in view of the situation in Syria
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Regulation (EU) No 36/2012 of 18 January 2012 concerning restrictive measures in view of the situation in Syria and repealing Regulation (EU) No 442/2011 (1), and in particular Article 32(1) thereof,
Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,
Whereas:
(1) |
On 18 January 2012 the Council adopted Regulation (EU) No 36/2012 concerning restrictive measures in view of the situation in Syria. |
(2) |
On the basis of a review of the measures, the entries for 59 persons subject to restrictive measures as set out in Annex II to Regulation (EU) No 36/2012 should be amended. |
(3) |
Nine entries should be deleted from the list of designated persons and entities. |
(4) |
Following the judgments of the General Court of 31 January 2019 in Case T-667/17, Alkarim for Trade and Industry v Council, and in Case T-559/17, Abdulkarim v Council, Alkarim for Trade and Industry and Mouhamad Wael Abdulkarim are not included in the list of natural and legal persons, entities and bodies subject to restrictive measures in Annex II to Regulation (EU) No 36/2012. |
(5) |
Annex II to Regulation (EU) No 36/2012 should therefore be amended accordingly, |
HAS ADOPTED THIS REGULATION:
Article 1
Annex II to Regulation (EU) No 36/2012 is amended as set out in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 17 May 2019.
For the Council
The President
E.O. TEODOROVICI
ANNEX
Annex II to Regulation (EU) No 36/2012 is amended as follows:
(1) |
Part A (‘Persons’) is amended as follows:
|
(2) |
in Part B (‘Entities’), the following entries are deleted:
|
20.5.2019 |
EN |
Official Journal of the European Union |
L 132/12 |
COMMISSION REGULATION (EU) 2019/799
of 17 May 2019
amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the removal from the Union list of the flavouring substance furan-2(5H)-one
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (1), and in particular Article 11(3) thereof,
Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (2), and in particular Article 7(6) thereof,
Whereas:
(1) |
Annex I to Regulation (EC) No 1334/2008 lays down a Union list of flavourings and source materials approved for use in and on foods and their conditions of use. |
(2) |
Commission Implementing Regulation (EU) No 872/2012 (3) adopted a list of flavouring substances and introduced that list in Part A of Annex I to Regulation (EC) No 1334/2008. |
(3) |
Annex I to Regulation (EC) No 1334/2008 may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application submitted by a Member State or by an interested party. |
(4) |
Part A of the Union list contains both evaluated flavouring substances and flavouring substances under evaluation. |
(5) |
The flavouring substance furan-2(5H)-one (FL No 10.066) is included in Annex I to Regulation (EC) No 1334/2008 as a flavouring substance under evaluation and for which additional scientific data was requested by the European Food Safety Authority (hereinafter ‘the Authority’). Such data was submitted by the applicant. |
(6) |
The Authority evaluated the submitted data and concluded in its scientific opinion of 11 December 2018 (4) that furan-2(5H)-one (FL No 10.066) raises a safety concern with respect to genotoxicity as it is genotoxic in vivo. |
(7) |
The use of furan-2(5H)-one (FL No 10.066) therefore does not comply with the general conditions of use for flavourings set out in Article 4(a) of Regulation (EC) No 1334/2008. Consequently, that substance should be removed from the list without delay in order to protect human health. |
(8) |
As regards the identification details of furan-2(5H)-one (FL No 10.066) the Authority provides in its opinion additional elements regarding the identity and characterisation of this substance which are not included in its current entry in Part A of Annex I of Regulation (EC) No 1334/2008. In order to ensure clarity and certainty regarding the identity of the substance and to help stakeholders to properly identify this substance, it is relevant to note that further identification details of furan-2(5H)-one (FL No 10.066) provided by the Authority in its Opinion are: the CAS No. is 497-23-4, its JECFA No is 2000 and the JECFA name is 4-hydroxy-2-butenoic acid gamma lactone. |
(9) |
As the substance raises a safety concern, The Commission should use the urgency procedure for the removal of furan-2(5H)-one from the Union list. Part A of Annex I to Regulation (EC) No 1334/2008 should therefore be amended accordingly. |
(10) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
HAS ADOPTED THIS REGULATION:
Article 1
Part A of Annex I to Regulation (EC) No 1334/2008 is amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 17 May 2019.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 354, 31.12.2008, p. 34.
(2) OJ L 354, 31.12.2008, p. 1.
(3) Commission Implementing Regulation (EU) No 872/2012 of 1 October 2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council and repealing Commission Regulation (EC) No 1565/2000 and Commission Decision 1999/217/EC (OJ L 267, 2.10.2012, p. 1).
(4) EFSA FAF Panel (EFSA Panel on Food Additives and Flavourings). Scientific Opinion on Flavouring Group Evaluation 217 Revision 2 (FGE.217Rev2), consideration of genotoxicity potential for alpha, beta unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones; EFSA Journal 2019;17(1):5568.
ANNEX
In Section 2 of Part A of Annex I to Regulation (EC) No 1334/2008, the following entry is deleted:
‘10.066 |
Furan-2(5H)-one |
|
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|
|
|
2 |
EFSA’ |
20.5.2019 |
EN |
Official Journal of the European Union |
L 132/15 |
COMMISSION REGULATION (EU) 2019/800
of 17 May 2019
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the extension of the use of carminic acid, carmine (E 120) in certain meat products traditional in French Overseas Territories
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (1), and in particular Article 10(3) thereof,
Whereas:
(1) |
Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in food and their conditions of use. |
(2) |
That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008 of the European Parliament and of the Council (2), either on the initiative of the Commission or following an application. |
(3) |
Carminic acid, Carmines (E 120) is a substance authorised as a colour in a variety of foods in accordance with Annex II to Regulation (EC) No 1333/2008. |
(4) |
On 23 June 2017, an application was submitted for the authorisation of the use of carminic acid, carmine (E 120) in certain non-heat-treated meat products. The application was subsequently made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008. |
(5) |
The applicant requested the authorisation for the use of carminic acid, carmine (E 120) in order to achieve the desired pink colour for certain traditional salted pork offal and beef specialities, such as groin de porc à la créole, queue de porc à la créole, pied de porc à la créole and paleron de bœuf à la créole to meet the consumer expectations in French Overseas Territories where these products have been part of a culinary tradition since the 18th century. |
(6) |
Carminic acid, carmine (E 120) is added to brine rich in salt into which offal is immersed. In products as marketed, the salt content is at least 70 g per kg of meat so as to safeguard microbiological stability and a long shelf life (often 12 months). Before cooking, the products need to be desalted in water. Carminic acid, carmine (E120) stays mainly on the surface of the meat and its stability to temperature, light, pH and oxygen ensures characteristic appearance even after cooking. |
(7) |
Recital 7 of Regulation (EC) No 1333/2008 stipulates that the approval of food additives should also take into account other factors relevant to the matter under consideration including, inter alia, traditional factors. Therefore, it is appropriate to maintain certain traditional products on the market in some Member States where the use of food additives comply with the general and specific conditions laid down in Regulation (EC) No 1333/2008. |
(8) |
On 18 November 2015, the European Food Safety Authority (the Authority) published a Scientific Opinion re-evaluating the safety of carminic acid, carmine (E 120) as a food additive (3). The Authority concluded that there was no reason to revise the acceptable daily intake value (ADI) of 2,5 mg carminic acid/kg bw/day and that the refined exposure estimates for the non-brand-loyal scenario are below the ADI for all population groups. Carminic acid, carmine (E120) is authorised for use in a wide variety of foods. The extended use is proposed for a few niche meat products and at a lower maximum level than the other currently authorised uses in food category 08.3.1 ‘Non-heat-treated meat products’ in Part E of Annex II to Regulation (EC) No 1333/2008. Since according to the Scientific Opinion meat products are not among the main contributors to the total exposure to carminic acid, carmine (E 120), it is not expected that the proposed use will have a significant impact on the overall exposure which therefore will remain below the ADI. |
(9) |
Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission has to seek the opinion of the Authority in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008, except where the update in question is not liable to have an effect on human health. Since the extended use of carminic acid, carmine (E120) is not liable to have an effect on human health it is not necessary to seek the opinion of the Authority. |
(10) |
Annex II to Regulation (EC) No 1333/2008 should therefore be amended accordingly. |
(11) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
HAS ADOPTED THIS REGULATION:
Article 1
Annex II to Regulation (EC) No 1333/2008 is amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 17 May 2019.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 354, 31.12.2008, p. 16.
(2) Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1).
(3) EFSA Journal 2015; 13(11):4288.
ANNEX
In Part E of Annex II to Regulation (EC) No 1333/2008, in food category 08.3.1 ‘Non-heat-treated meat products’, the following new entry for E 120 is inserted after the entry for E 110:
|
‘E 120 |
Carminic acid, Carmine |
50 |
|
only the following traditional salted pork offal and beef specialties: groin de porc à la créole, queue de porc à la créole, pied de porc à la créole and paleron de bœuf à la créole. These products are consumed after desalting and cooking.’ |
20.5.2019 |
EN |
Official Journal of the European Union |
L 132/18 |
COMMISSION REGULATION (EU) 2019/801
of 17 May 2019
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of mono- and diglycerides of fatty acids (E 471) on certain fresh fruits
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (1), and in particular Article 10(3) thereof,
Whereas:
(1) |
Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in food and their conditions of use. |
(2) |
That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008 of the European Parliament and of the Council (2), either on the initiative of the Commission or following an application. |
(3) |
Mono- and diglycerides of fatty acids (E 471) is a food additive authorised in a variety of foods in accordance with Annex II to Regulation (EC) No 1333/2008. |
(4) |
On 17 February 2017, an application was submitted for the authorisation of the use of mono- and diglycerides of fatty acids of fatty acids (E 471) on all fresh fruits and vegetables. The application was subsequently made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008. |
(5) |
Mono- and diglycerides of fatty acids (E 471), when used as a glazing agent for a surface treatment of fresh fruits and vegetables, form a thin, inert, physical barrier layer against moisture loss and oxidation to protect the nutritional quality and extend the shelf life. According to the applicant, the proposed use would address an increasing demand for year-round availability of fresh produce, reduce food waste and improve the efficiency of natural resource use in agricultural production through reduced losses and use of lower carbon dioxide emission methods of transportation. |
(6) |
The application was discussed by the Working Party of Governmental Experts on Additives. The Working Party noted that there is a technological need in particular for the external treatment of certain fruits which are mainly imported from countries with a tropical climate and which need to be protected during long transports. Peels of those fruits are usually not consumed. |
(7) |
On 10 November 2017, the European Food Safety Authority (‘the Authority’) published a scientific opinion re-evaluating the safety of mono- and diglycerides of fatty acids (E 471) as food additives (3). The Authority concluded that there was no need for a numerical acceptable daily intake and that the food additive mono- and diglycerides of fatty acids (E 471) was of no safety concern at the reported uses and use levels. Such conclusion is used for substances of a very low safety concern and only if there is reliable information for both exposure and toxicity and there is a low probability of adverse health effects in humans at doses that do not induce nutritional imbalance in animals (4). However, the Authority recommended some modifications of the EU specifications for the food additive mono- and diglycerides of fatty acids (E 471). The Commission will address these recommendations separately following the general approach for the Authority's opinions in which some concerns have been identified (5). |
(8) |
In addition, mono- and diglycerides of fatty acids (E 471) are intended to be used for the external treatment and are not expected to migrate into the internal edible part of the fruits. The treatment on fruits of which the peels are usually not consumed is not liable to have an effect on human health. It is therefore appropriate to allow the use of mono- and diglycerides of fatty acids (E 471) on certain fruits that are mainly imported from countries with a tropical/subtropical climate and of which peels are usually not consumed, i.e. citrus fruit, melons, pineapples, bananas, papayas, mangoes, avocados and pomegranates. |
(9) |
Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission has to seek the opinion of the Authority in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008, except where the update in question is not liable to have an effect on human health. Since the authorisation of use of mono- and diglycerides of fatty acids (E 471) on citrus fruit, melons, pineapples, bananas, papayas, mangoes, avocados and pomegranates constitutes an update of that list which is not liable to have an effect on human health, it is not necessary to seek the opinion of the Authority. |
(10) |
Annex II to Regulation (EC) No 1333/2008 should therefore be amended accordingly. |
(11) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
HAS ADOPTED THIS REGULATION:
Article 1
Annex II to Regulation (EC) No 1333/2008 is amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 17 May 2019.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 354, 31.12.2008, p. 16.
(2) Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1).
(3) EFSA Journal 2017;15(11):5045
(4) EFSA Journal 2014;12(6):3697, Statement on a conceptual framework for the risk assessment of certain food additives re-evaluated under Commission Regulation (EU) No 257/2010.
(5) https://ec.europa.eu/food/sites/food/files/safety/docs/fs-improv-approach.pdf
ANNEX
In Part E of Annex II to Regulation (EC) No 1333/2008, in food category 04.1.1 ‘Entire fresh fruit and vegetables’, the following new entry is inserted after the entry for E 464:
|
‘E 471 |
Mono- and diglycerides of fatty acids |
quantum satis |
|
Only for the surface treatment of citrus fruit, melons, pineapples, bananas, papayas, mangoes, avocados and pomegranates’ |
20.5.2019 |
EN |
Official Journal of the European Union |
L 132/21 |
COMMISSION IMPLEMENTING REGULATION (EU) 2019/802
of 17 May 2019
correcting the Greek language version of Implementing Regulation (EU) 2018/775 laying down rules for the application of Article 26(3) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers, as regards the rules for indicating the country of origin or place of provenance of the primary ingredient of a food
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (1), and in particular Article 26(8) thereof,
Whereas:
(1) |
The Greek language version of Commission Implementing Regulation (EU) 2018/775 (2) contains errors in Article 1(1) and (2) as regards the scope of that Regulation. |
(2) |
The Greek language version of Implementing Regulation (EU) 2018/775 should therefore be corrected accordingly. The other language versions are not affected. |
(3) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
HAS ADOPTED THIS REGULATION:
Article 1
(does not concern the English language)
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 17 May 2019.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 304, 22.11.2011, p. 18.
(2) Commission Implementing Regulation (EU) 2018/775 of 28 May 2018 laying down rules for the application of Article 26(3) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers, as regards the rules for indicating the country of origin or place of provenance of the primary ingredient of a food (OJ L 131, 29.5.2018, p. 8).
20.5.2019 |
EN |
Official Journal of the European Union |
L 132/23 |
COMMISSION IMPLEMENTING REGULATION (EU) 2019/803
of 17 May 2019
concerning the technical requirements regarding the content of quality reports on European statistics on natural gas and electricity prices pursuant to Regulation (EU) 2016/1952 of the European Parliament and of the Council
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2016/1952 of the European Parliament and of the Council of 26 October 2016 on European statistics on natural gas and electricity prices (1), and in particular Article 7(5) thereof,
Whereas:
(1) |
Regulation (EU) 2016/1952 sets out the framework for producing comparable European statistics on natural gas and electricity prices. |
(2) |
In accordance with Article 7(3) of Regulation (EU) 2016/1952, every 3 years, Member States are to provide the Commission (Eurostat) with standard quality reports on the data in accordance with the quality criteria laid down in Article 12(1) of Regulation (EC) No 223/2009 of the European Parliament and of the Council (2). Those reports are to include information on the scope and collection of the data, the calculation criteria, the methodology and data sources used, and any changes thereto. |
(3) |
In accordance with Article 7(4) of Regulation (EU) 2016/1952, the Commission (Eurostat) is to assess the quality of the data submitted and is to use that assessment and an analysis of the quality reports in order to prepare and publish a report on the quality of European statistics covered by the Regulation (EU) 2016/1952. |
(4) |
Following the entry into force of Regulation (EU) 2016/1952, the Commission (Eurostat) worked closely with Member States to assess the relevant technical quality assurance requirements regarding the content and the appropriate timing of the quality reports. |
(5) |
The measures provided for in this Regulation are in accordance with the opinion of the European Statistical System Committee, |
HAS ADOPTED THIS REGULATION:
Article 1
(1) The technical quality assurance requirements regarding the content of the quality reports on the data on natural gas and electricity prices are set out in the Annex.
(2) Member States shall submit the first quality reports by 15 June 2019.
(3) Each quality report shall cover the full years elapsed since the date of the previous quality report. However, the first quality reports shall cover reference years 2017 and 2018.
Article 2
The quality reports shall be provided through the single entry point provided by the Commission (Eurostat) in order to enable the Commission (Eurostat) to receive those quality reports by electronic means.
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 17 May 2019.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 311, 17.11.2016, p. 1.
(2) Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament and of the Council on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (OJ L 87, 31.3.2009, p. 164).
ANNEX
TECHNICAL QUALITY ASSURANCE REQUIREMENTS REGARDING THE CONTENT OF THE QUALITY REPORTS OF EUROPEAN STATISTICS ON NATURAL GAS AND ELECTRICITY PRICES
The quality reports shall include information on all the quality criteria laid down in Article 12(1) of Regulation (EC) No 223/2009.
1. RELEVANCE
Member States shall provide the following information in the quality reports:
(a) |
a description of users, their respective needs and a justification of these needs; |
(b) |
procedures used to measure user satisfaction and produce the results; |
(c) |
the extent to which the required statistics are available. |
2. ACCURACY
The quality reports shall contain:
(a) |
an accuracy assessment which summarises the various dataset components; |
(b) |
a description of the sampling errors; |
(c) |
a description of any other errors. |
3. TIMELINESS AND PUNCTUALITY
Member States shall report on:
(a) |
the length of time between the event or phenomenon they describe and the data availability (timeliness); |
(b) |
the length of time between the target date for data delivery and the actual data delivery date (punctuality); |
(c) |
the number of iterations needed in order to have fully validated data (validation iterations). |
4. ACCESSIBILITY AND CLARITY
Member States shall report on the conditions and means by which users can:
(a) |
obtain and use the data (including, but not limited to news releases, publications, online databases, micro data access); |
(b) |
interpret the data such as providing documentation on methodology and quality management. |
5. COMPARABILITY
Member States shall report on the extent to which statistics are comparable:
(a) |
between geographical areas; |
(b) |
over time. |
6. COHERENCE
Member States shall report on the extent to which statistics are:
(a) |
reconcilable with data obtained through other sources (cross domain coherence); |
(b) |
consistent within a given dataset (internal coherence). |
Member States shall also report on the following additional quality aspects:
1. QUALITY MANAGEMENT:
Member States shall report on the systems and frameworks in place to manage the quality of statistical products and processes. They shall also report on their assessment of the quality of the data.
2. DATA REVISION:
Member States shall explain why validated data have been revised. The reasons may include information of new source of data available, new methods or other relevant information. The report shall also include the date, the size and the magnitude of the revisions.
In accordance with Article 7(3) of Regulation (EU) 2016/1952, those reports shall include information on the scope and collection of the data, the calculation criteria, the methodology and data sources used, and any changes made.
1. STATISTICAL PRESENTATION
Member States shall provide the following description of the disseminated data which can be displayed to users as tables, graphs or maps:
(a) |
data description; |
(b) |
classification system; |
(c) |
sector coverage; |
(d) |
statistical concepts and definitions; |
(e) |
statistical unit; |
(f) |
statistical population; |
(g) |
reference area (geographical scope); |
(h) |
time coverage (length of time for which data are available); |
(i) |
reference period (period covered by the report); |
(j) |
unit of measure. |
2. STATISTICAL PROCESSING:
The quality reports shall cover a description of all procedures used to collect, validate and compile the data and to derive new information.
3. RELEASE POLICY
The quality reports shall report on the rules for disseminating the data at national level.
4. FREQUENCY OF DISSEMINATION
The reports shall also indicate the frequency with which the data is disseminated at national level.
In line with the statistical principles laid down in points (e) and (f) of Article 2(1) of Regulation (EC) No 223/2009, Member States shall report on:
1. CONFIDENTIALITY
The quality reports shall contain information on the legislative measures or other formal procedures, which prevent any unauthorised disclosure of data that could directly or indirectly cause a person or economic entity to be identified. They will also outline the rules applied to ensure statistical confidentiality and prevent unauthorised disclosure.
2. COST AND BURDEN:
The quality reports shall contain information on the cost and burden associated with the collection and production of the statistical product.
20.5.2019 |
EN |
Official Journal of the European Union |
L 132/28 |
COMMISSION IMPLEMENTING REGULATION (EU) 2019/804
of 17 May 2019
concerning the renewal of the authorisation of organic form of selenium produced by Saccharomyces cerevisiae CNCM I-3060 and of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 as feed additives for all animal species and repealing Regulations (EC) No 1750/2006 and (EC) No 634/2007
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
Whereas:
(1) |
Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting and renewing such authorisation. |
(2) |
The organic form of selenium produced by Saccharomyces cerevisiae CNCM I-3060 was authorised for 10 years as a feed additive for all animal species by Commission Regulation (EC) No 1750/2006 (2). Selenomethionine produced by Saccharomyces cerevisiae NCYC R397 was authorised for 10 years as a feed additive for all animal species by Commission Regulation (EC) No 634/2007 (3). |
(3) |
In accordance with Article 14 of Regulation (EC) No 1831/2003, applications were submitted for the renewal of the authorisation of the organic form of selenium produced by Saccharomyces cerevisiae CNCM I-3060 and of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 as feed additives for all animal species, requesting those additives to be classified in the additive category ‘nutritional additives’. Those applications were accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003. |
(4) |
The European Food Safety Authority (‘the Authority’) concluded in its opinions of 5 July 2018 (4) and 28 November 2018 (5) that the applicants have provided data demonstrating that the additives comply with the conditions of authorisation under the proposed conditions of use. The Authority confirmed its previous conclusions that the organic form of selenium produced by Saccharomyces cerevisiae CNCM I-3060 and the selenomethionine produced by Saccharomyces cerevisiae NCYC R397 do not have adverse effects on animal health, consumer safety or the environment. It also stated for the organic form of selenium produced by Saccharomyces cerevisiae CNCM I-3060 capacities to be a respiratory sensitizer and hazardous upon inhalation, and for selenomethionine produced by Saccharomyces cerevisiae NCYC R397 capacities to be an eye and mucosae irritant, and a skin and respiratory sensitizer. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. Finally, the Authority recommends changing the denomination of the additives. |
(5) |
It is appropriate to update the methods of analysis for selenium and selenomethionine based on the respective recent reports of the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
(6) |
The assessment of the organic form of selenium produced by Saccharomyces cerevisiae CNCM I-3060 and of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of those additives should be renewed as specified in the Annex to this Regulation. |
(7) |
As a consequence of the renewal of the authorisations of the organic form of selenium produced by Saccharomyces cerevisiae CNCM I-3060 and of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 as feed additives under the conditions laid down in the Annex to this Regulation, Regulations (EC) No 1750/2006 and (EC) No 634/2007 should be repealed. |
(8) |
Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for the organic form of selenium produced by Saccharomyces cerevisiae CNCM I-3060 and for selenomethionine produced by Saccharomyces cerevisiae NCYC R397, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation. |
(9) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
HAS ADOPTED THIS REGULATION:
Article 1
The authorisation of the additives specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, is renewed subject to the conditions laid down in that Annex.
Article 2
1. The organic form of selenium produced by Saccharomyces cerevisiae CNCM I-3060, selenomethionine produced by Saccharomyces cerevisiae NCYC R397 and premixtures containing these substances, which are produced and labelled before 9 December 2019 in accordance with the rules applicable before 9 June 2019 may continue to be placed on the market and used until the existing stocks are exhausted.
2. Feed materials and compound feed containing the substances referred to in point 1, which are produced and labelled before 9 June 2020 in accordance with the rules applicable before 9 June 2019 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
3. Feed materials and compound feed containing the substances referred to in point 1, which are produced and labelled before 9 June 2021 in accordance with the rules applicable before 9 June 2019 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
Article 3
Regulations (EC) No 1750/2006 and (EC) No 634/2007 are repealed.
Article 4
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 17 May 2019.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 268, 18.10.2003, p. 29.
(2) Commission Regulation (EC) No 1750/2006 of 27 November 2006 concerning the authorisation of selenomethionine as a feed additive (OJ L 330, 28.11.2006, p. 9).
(3) Commission Regulation (EC) No 634/2007 of 7 June 2007 concerning the authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 as a feed additive (OJ L 146, 8.6.2007, p. 14).
(4) EFSA Journal 2018;16(7):5386.
(5) EFSA Journal 2019;17(1):5539.
ANNEX
Identification number of the additive |
Name of the holder of authorisation |
Additive |
Composition, chemical formula, description, analytical method. |
Species or category of animal |
Maximum age |
Minimum content |
Maximum content |
Other provisions |
End of period of authorisation |
||||||||||||||||||||||||
Selenium in mg/kg of complete feed with a moisture content of 12 % |
|||||||||||||||||||||||||||||||||
Category of nutritional additives. Functional group: compounds of trace elements |
|||||||||||||||||||||||||||||||||
3b810 |
— |
Selenised yeast Saccharomyces cerevisiae CNCM I-3060, inactivated |
Additive composition Preparation of organic selenium:
Characterisation of the active substance Selenomethionine produced by Saccharomyces cerevisiae CNCM I-3060 Chemical formula: C5H11NO2Se Analytical method (1) For the determination of selenomethionine in the feed additive:
For the determination of total selenium in the feed additive:
For the determination of total selenium in premixtures, compound feed and feed materials:
|
All species |
— |
|
0,50 (total) |
|
9 June 2029 |
||||||||||||||||||||||||
3b811 |
— |
Selenised yeast Saccharomyces cerevisiae NCYC R397, inactivated |
Additive composition Preparation of organic selenium:
Characterisation of the active substance Selenomethionine produced by Saccharomyces cerevisiae NCYC R397 Chemical formula: C5H11NO2Se Analytical method (1) For the determination of selenomethionine in the feed additive:
For the determination of total selenium in the feed additive:
For the determination of total selenium in premixtures, compound feed and feed materials:
|
All species |
— |
|
0,50 (total) |
|
9 June 2029 |
(1) Details of the analytical methods are available at the following address of the European Union Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/authorisation/evaluation_reports/Pages/index.aspx
20.5.2019 |
EN |
Official Journal of the European Union |
L 132/33 |
COMMISSION IMPLEMENTING REGULATION (EU) 2019/805
of 17 May 2019
concerning the authorisation of a preparation of muramidase produced by Trichoderma reesei DSM 32338 as a feed additive for chickens for fattening and minor poultry species for fattening (holder of authorisation DSM Nutritional Products Ltd, represented in EU by DSM Nutritional Products Sp. Z o.o)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
Whereas:
(1) |
Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. |
(2) |
In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of muramidase produced by Trichoderma reesei DSM 32338. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation. |
(3) |
That application concerns the authorisation of a preparation of muramidase produced by Trichoderma reesei DSM 32338 as a feed additive for chickens for fattening and minor poultry species for fattening, to be classified in the additive category ‘zootechnical additives’. |
(4) |
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 14 June 2018 (2) that, under the proposed conditions of use, the preparation of muramidase produced by Trichoderma reesei DSM 32338 does not have an adverse effect on animal health, consumer safety or the environment. It was also concluded that the additive may have a skin/eyes irritancy potential and skin sensitisation potential. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that the additive showed improvements of the feed to gain ratio in chickens for fattening. The Authority considered that this conclusion can be extrapolated to minor poultry species for fattening. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
(5) |
The assessment of the preparation of muramidase produced by Trichoderma reesei DSM 32338 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation. |
(6) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
HAS ADOPTED THIS REGULATION:
Article 1
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in the Annex.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 17 May 2019.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 268, 18.10.2003, p. 29.
(2) EFSA Journal 2018;16(7):5342.
ANNEX
Identification number of the additive |
Name of the holder of authorisation |
Additive |
Composition, chemical formula, description, analytical method |
Species or category of animal |
Maximum age |
Minimum content |
Maximum content |
Other provisions |
End of period of authorisation |
||||
Units of activity /kg of complete feedingstuff with a moisture content of 12 % |
|||||||||||||
Category of zootechnical additives. Functional group: other zootechnical additives (improvement of the feed to gain ratio) |
|||||||||||||
4d16 |
DSM Nutritional Products Ltd represented in the EU by DSM Nutritional Products Sp. Z o.o |
Muramidase (EC 3.2.1.17) |
Additive composition Preparation of muramidase (EC 3.2.1.17) (lysozyme) produced by Trichoderma reesei (DSM 32338) having a minimum activity of 60 000 LSU(F)/g (1) Solid and liquid forms Characterisation of the active substance Muramidase (EC 3.2.1.17) (lysozyme) produced by Trichoderma reesei (DSM 32338) Method of analysis (2) For the quantification of muramidase: fluorescence-based enzyme assay method that determines the enzyme-catalysed depolymerisation of a fluorescein-labelled peptidoglycan preparation at pH 6,0 and 30 °C. |
Chickens for fattening Minor poultry species for fattening |
— |
25 000 LSU(F) |
— |
|
9 June 2029 |
(1) One LSU(F) unit is defined as the amount of enzyme that increases the fluorescence of 12,5 μg/ml fluorescein-labelled peptidoglycan per minute at pH 6,0 and 30 °C by a value that corresponds to the fluorescence of approximately 0,06 nmol fluorescein isothiocyanate isomer I.
(2) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
DECISIONS
20.5.2019 |
EN |
Official Journal of the European Union |
L 132/36 |
COUNCIL DECISION (CFSP) 2019/806
of 17 May 2019
amending Decision 2013/255/CFSP concerning restrictive measures against Syria
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on European Union, and in particular Article 29 thereof,
Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,
Whereas:
(1) |
On 31 May 2013 the Council adopted Decision 2013/255/CFSP (1). |
(2) |
On 28 May 2018 the Council adopted Decision (CFSP) 2018/778 (2), extending the restrictive measures set out in Decision 2013/255/CFSP until 1 June 2019. |
(3) |
On the basis of a review, the Council decided that the restrictive measures should be extended until 1 June 2020. |
(4) |
The entries for 59 persons subject to restrictive measures as set out in Annex I to Decision 2013/255/CFSP should be amended. |
(5) |
Nine entries should be deleted from the list of designated persons and entities. |
(6) |
Following the judgments of the General Court of 31 January 2019 in Case T-667/17, Alkarim for Trade and Industry v Council, and in Case T-559/17, Abdulkarim v Council, Alkarim for Trade and Industry and Mouhamad Wael Abdulkarim are not included in the list of natural and legal persons, entities and bodies subject to restrictive measures in Annex I to Decision 2013/255/CFSP. |
(7) |
Decision 2013/255/CFSP should therefore be amended accordingly, |
HAS ADOPTED THIS DECISION:
Article 1
Decision 2013/255/CFSP is amended as follows:
(1) |
Article 34 is replaced by the following: ‘Article 34 This Decision shall apply until 1 June 2020. It shall be kept under constant review. It may be renewed, or amended as appropriate, if the Council deems that its objectives have not been met.’; |
(2) |
Annex I is amended as set out in the Annex to this Decision. |
Article 2
This Decision shall enter into force on the day following that of its publication in the Official Journal of the European Union.
Done at Brussels, 17 May 2019.
For the Council
The President
E.O. TEODOROVICI
(1) Council Decision 2013/255/CFSP of 31 May 2013 concerning restrictive measures against Syria (OJ L 147, 1.6.2013, p. 14).
(2) Council Decision (CFSP) 2018/778 of 28 May 2018 amending Decision 2013/255/CFSP concerning restrictive measures against Syria (OJ L 131, 29.5.2018, p. 16)
ANNEX
Annex I to Decision 2013/255/CFSP is amended as follows:
(1) |
Part A (‘Persons’) is amended as follows:
|
(2) |
in Part B (‘Entities’), the following entries are deleted:
|